Many people suffer from severe abdominal pain created by the formation of adhesions. An adhesion is the abnormal union of separate tissue surfaces that often occurs during the healing process of injured cells, tissues and organs. Adhesions may result after any trauma sustained by the body such as a surgery or a wound.
Adhesions are indiscriminate as they may form on organs ranging in diversity from the heart to the female reproductive organs. The formation of adhesions creates serious medical problems because they often interfere with the proper functioning of an organ and may result in the total loss of function in that organ.
To date, the successful treatment of adhesions varies from organ to organ. While one form of adhesion treatment may work well on a specific organ, it may not work at all on another organ because organs differ in various ways such as in size, shape, function, and chemical composition.
One form of treatment consists of the application of an absorbable adhesion barrier made of oxidized regenerated cellulose. This adhesion barrier and a method of preventing adhesions by the use of this barrier are disclosed in U.S. Pat. Nos. 5,002,551 and 5,007,916 ('551 and '916 patents). The disclosed adhesion barrier is a sterile knitted fabric prepared by the controlled oxidation of regenerated cellulose. The barrier is made available in 3".times.4" single layer pieces. Typically a dry piece of the adhesion barrier is laid upon the surface of an injured organ or upon tissue surrounding the injured organ whereupon it turns into a gel within one to two days. The gel adheres to the surface of the injured organ or surrounding tissue via ionic bonds. This prevents the injured surface area from directly contacting nearby tissue while healing, thereby reducing adhesion formation between the organ and nearby tissue.
The gel also regulates proper protein concentration and prevents fibrin deposition at the injured organ surface during the healing process, thereby eliminating thick scar tissue that could form and cause adhesions. After about four to six weeks the gel is naturally absorbed by macrophages of the body. By this time, the injured surface has partially or completely healed without forming adhesions by growing a layer of epithelium over the injured organ surface beneath the adhesion barrier gel.
The adhesion barrier disclosed in the '551 and '916 patents is used to reduce adhesion formation in gynecologic pelvic surgery. The viability of this adhesion barrier in gynecologic pelvic surgery is due to a number of factors. In comparison with various other organs, gynecological organs, such as the uterus and ovaries, are quite small and symmetrical in shape. It is therefore fairly simple to place one or a couple small pieces of this barrier on these organs to adequately cover them or to place the barrier on the pelvic sidewall to treat the affected area of the organ.
Another factor adding to the successful use of this adhesion barrier in gynecologic pelvic surgery is that gynecological organs do not move significantly or alter their shape during normal functioning. Thus, a piece of the adhesion barrier can simply be laid upon the organ without the risk of becoming displaced by movement during normal functioning of the organ. Furthermore, the barrier adheres succinctly to these organs because the surface area of such organs is fairly dry, especially since these organs are not fluid filled. Fluid filled organs, on the other hand, diffuse fluid through the organ wall when injured. Thus, the surface area of these fluid filled organs are moist and it was thought, would cause the adhesion barrier to float off of the organ, hindering the treatment and prevention of adhesions.
The success of adhesion barrier treatment is greatly reduced by the presence of an infection in the organ. The body will perceive the infection and possibly the barrier as foreign and quickly consume the barrier along with the infection. The presence of virulent bacteria in the organ creates greater chances of infection and the resulting consumption of the barrier. The barrier may even serve as an energy source for the infection and bacteria. Gynecological organs do not normally house such virulent bacteria. This is one reason that adhesion barriers have been successfully used on gynecological organs.
Of all the types of adhesions, adhesions of the bowel involve some of the most serious problems. Since the small intestine alone has an average adult length of 9 feet in a healthy person, adhesions can be numerous as loops of the small intestine are in constant contact with each other creating an environment conducive to the formation of adhesions. Another source of adhesion formation is between the peritoneum and intestines, as the intestines are completely encased by the peritoneum. These adhesions create severe abdominal pain and interfere with the digestive process, which can be life threatening.
A number of procedures have been used for treating adhesions of the bowel, but all have been unsuccessful. Some of these procedures include ultrasound treatments and other, more complicated, surgical techniques. The known, surgical techniques can be dangerous to the patient by causing additional complications, such as infection. Various medications have also been administered to patients suffering from bowel adhesions. Some medications have resulted in unwanted side effects such as blindness, while other medications have resulted in death due to the medication's high level of toxicity.
Certain characteristics of the bowel make adhesion treatment and prevention difficult. The size of the bowel creates the possibility of numerous adhesions. The small bowel winds back and forth in the abdominal region, thereby being in direct and constant contact with itself and the peritoneum. It is therefore nearly impossible for a specific bowel surface to heal without being in direct contact with itself or the peritoneum. Furthermore, successive waves of involuntary contractions pass along the walls of the intestines during digestion, moving the intestines and further increasing the chance of one area of the intestine coming into contact with surrounding tissue.
To complicate matters, the bowel is a fluid filled organ which is prone to cause infection upon injury as fluid diffuses through the bowel wall. The bowel also contains virulent bacteria which significantly increases the chance of infection. As a result of all of these complicating factors, prior to my invention adhesions of the bowel had yet to be successfully treated in a consistent, predictable fashion.